(1995; 156 pages)
8.5 million in 1992.
2. Pharmaceutical import and consumption
Total imports of pharmaceuticals in 1992 were estimated to be US$ 112.79 million. Main exporting countries were: Bulgaria 1.5%, France 74%, Germany 1.5%, Italy 4%, Jordan 35%.
Drug consumption in 1992 in the public and private sector amounted to US$ 29 and US$ 131 million respectively. The total public sector drug budget for 1992 was US$ 27 million.
3. Drug policy and essential drugs list
The 8th Final Report of Health Plan of September 1991 reflects the national drug policy of the country. The policy covers all aspects relating to drug regulatory control, drug registration, drug procurement and quality assurance. There is a plan, developed in April 1993, for the implementation of the policy.
The National Essential Drugs List of Tunisia was formulated on 24 September 1991 and is used for procurement in the public sector. The list comprises 304 products.
4. Infrastructure and functioning
4.1 Drug regulation and registration
Law No. 85-91 of 22 November 1985 is used for the regulation of human drugs in Tunisia. Guidelines for registration of drugs were developed on 15 December 1990 but actual registration started in 1992. Decree No. 90.1400 of 3 September 1990 defines among other things, regulation of GMP and quality control, storage, labelling, nomenclature and promotion.
The Department of Pharmacy and Medicines is responsible for the development of legislation. The Division of Registration coordinates drug registration. All drugs imported into the country are subject to registration.
4.2 Public and private procurement
Pharmacie Centrale de Tunisie is the sole drug importing agency in the country. Procurement is done by means of open and restricted tender as well as through negotiation. In 1992, 450 products were purchased from manufacturers in France.
4.3 Quality control of drugs
Drugs are tested by the National Drug Quality Control Laboratory of Tunisia before authorization for marketing, to ensure conformity to open tender and in post-marketing surveillance. In 1992, 741 samples were sent for testing and 78% passed the tests. Samples are sent for testing after receipt and after payment and following complaints.
The Division of Pharmacy Inspection under the Pharmacy and Medicines Department is responsible for the inspection of drug establishments.
5. Operation of the WHO Certification Scheme
Tunisia accepted the Scheme on 8 February 1978 and the responsible authority is the Direction de la Pharmacie des Laboratoires et des Médicaments de la Santé, Place Bab Saadoum, Tunisia. A copy of the marketing authorization from the country of origin, attestation of sale of the product in the country of origin and batch certificate are requested for registration and import of drugs into the country. Attestation of import authorization is sent to Customs officers and to the procurement agency to notify them on products registered in the country. A circular is made twice a week and official nomenclature of products authorized for importation is given to all pharmacists. Contact with competent authorities of exporting countries is made directly or through intermediaries.
• A Certificate of a Pharmaceutical Product is not a prerequisite for drug registration.
• All drugs imported into the country are registered.
• Marketing authorization, attestation of sale of the product in the country of origin and batch certificate are required for registration and for importation of drugs.
• Quality assurance of marketed drugs is effective.